,,ii  #aah? ,,congress  #b;d ,session   
,s4 #ddfi  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,june #e1 #bjbd,mr4    
,c>d9 7= himself & ,mrs4 ,blackburn7    
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,f9ance  ,a ,,bill  ,to improve !       
und]/&+ (1 & promote access to treatm5t 
=1 *ronic kidney disease1 & = o!r       
purposes4  #a4 ,%ort title2 table (     
cont5ts  7a7 ,%ort title ,?is ,act may  
be cit$ z ! ,*ronic ,kidney ,disease    
,improvem5t 9 ,rese>* & ,treatm5t ,act (
 #bjbd4  7b7 ,table ( cont5ts ,! table (
 cont5ts = ?is ,act is z foll[s3 ,sec4  
#a4 ,%ort title2 table ( cont5ts4,,title
 ,i--,prev5t+ kidney disease by exp&+   
education & awareness,sec4 #aja4 ,exp&+ 
,m$ic>e annual wellness b5efit to       
include kidney disease scre5+4,sec4     
#ajb4 ,increas+ access to ,m$ic>e kidney
 disease education b5efit4,sec4 #ajc4   
,und]/&+ ! progression ( kidney disease 
& treatm5t ( kidney failure 9 m9ority   
populations4,,title ,,ii--,inc5tiviz+   

kidney c>e innovation,sec4 #bja4 ,ref9+ 
! end-/age r5al disease paym5t sy/em to 
improve accuracy 9 paym5t & support     
!rapies4,sec4 #bjb4 ,ensur+ ,m$ic>e     
,advantage supports kidney c>e          
innovative !rapies4,sec4 #bjc4 ,improv+ 
pati5t lives & quality ( c>e ?r\gh      
rese>* & innovation4,,title             
,,iii--,address+ ! kidney c>e work=ce   
crisis4,sec4 #cja4 ,improv+ pati5t      
decision mak+ & transp>5cy by           
consolidat+ & mod]niz+ quality          
programs4,sec4 #cjb4 ,ensur+ accuracy & 
/ability 9 kidney c>e paym5t4,,title    
,,iv--,exp&+ pati5t *oice (             
coverage,sec4 #dja4 ,m$igap cov]age =   
b5efici>ies ) end-/age r5al disease4  ,i
 ,prev5t+ kidney disease by exp&+       
education & aw>5ess  #aja4 ,exp&+       
,m$ic>e annual wellness b5efit to       
include kidney disease scre5+  7a7 ,9   
g5]al ,section #ahfa7ww77#b7 ( ! ,social
 ,security ,act 7#db ,u4,s4,c4          
#aciex7ww77#b77 is am5d$-- 7#a7 by mov+ 
subp>agraph 7,n7 #b ems to ! left2  7#b7

 by r$esignat+ subp>agraph 7,o7 z       
subp>agraph 7,p72 &  7#c7 by ins]t+ aft]
 subp>agraph 7,n7 ! foll[+ new          
subp>agraph3  7,o7 ,*ronic kidney       
disease scre5+ z def9$ by ! ,secret>y4  
4  7b7 ,effective date ,! am5dm5ts made 
by ?is section apply to items & s]vices 
furni%$ on or aft] ,janu>y #a1 #bjbe4   
#ajb4 ,increas+ access to ,m$ic>e kidney
 disease education b5efit  7a7 ,9 g5]al 
,section #ahfa7;ggg7 ( ! ,social        
,security ,act 7#db ,u4,s4,c4           
#aciex7ggg77 is am5d$-- 7#a7 9 p>agraph 
7#a7-- 7,a7 9 subp>agraph 7,a71 by      
ins]t+ or /age ,v aft] /age ,,iv2 &     
7,b7 9 subp>agraph 7,b71 by ins]t+ or ( 
a physician assi/ant1 nurse practition]1
 or cl9ical nurse speciali/ 7z def9$ 9  
section #ahfa7;aa77#e77 assi/+ 9 !      
treatm5t ( ! individual's kidney        
condition aft] kidney condition2 &  7#b7
 9 p>agraph 7#b7-- 7,a7 by /rik+        
subp>agraph 7,b72 &  7,b7 9 subp>agraph 
7,a7-- 7i7 by /rik+ 7,a7 aft] 7#b72     
7ii7 by /rik+ & at ! end ( clause 7i72  

7iii7 by /rik+ ! p]iod at ! end ( clause
 7ii7 & ins]t+ 2 &2  7iv7 by r$esignat+ 
clauses 7i7 & 7ii7 z subp>agraphs 7,a7 &
 7,b71 respectively1 & ind5t+           
appropriately2 &  7v7 by add+ at ! end !
 foll[+3  7,c7 a r5al dialysis facility 
subject to ! requirem5ts ( section      
#ahha7;b77#a7 ) p]sonnel :o-- 7i7       
provide ! s]vices describ$ 9 p>agraph   
7#a72 &  7ii7 is a physician 7z def9$ 9 
subsection 7r77#a77 or a physician      
assi/ant1 nurse practition]1 or cl9ical 
nurse speciali/ 7z def9$ 9 subsection   
7aa77#e774  4  7b7 ,paym5t to r5al      
dialysis facilities ,section #ahha7;b7 (
 ! ,social ,security ,act 7#db ,u4,s4,c4
 #acierr7b77 is am5d$ by add+ at ! end !
 foll[+ new p>agraph3  7#ae7 ,= purposes
 ( p>agraph 7#ad71 ! s+le paym5t = r5al 
dialysis s]vices "u su* p>agraph %all n 
take into acc\nt ! am\nt ( paym5t =     
kidney disease education s]vices 7z     
def9$ 9 section #ahfa7;ggg774 ,in/ead1  
paym5t = su* s]vices %all be made to !  
r5al dialysis facility on an            

assignm5t-relat$ basis "u section #ahdh4
  4  7c7 ,effective date ,! am5dm5ts    
made by ?is section apply to kidney     
disease education s]vices furni%$ on or 
aft] ,janu>y #a1 #bjbe4  #ajc4 ,und]/&+ 
! progression ( kidney disease &        
treatm5t ( kidney failure 9 m9ority     
populations  7a7 ,/udy ,! ,secret>y (   
,heal? & ,human ,s]vices 79 ?is section 
ref]r$ to z ! ,secret>y7 %all conduct a 
/udy on-- 7#a7 ! social1 behavioral1 &  
biological factors associat$ ) kidney   
disease onset & progression2  7#b7 ef=ts
 to sl[ ! progression ( kidney disease 9
 m9ority populations t are              
disproportionately affect$ by su*       
disease2 &  7#c7 treatm5t patt]ns       
associat$ ) provid+ c>e1 "u ! ,m$ic>e   
program "u title ,,xviii ( ! ,social    
,security ,act1 ! ,m$icaid program "u   
title ,,xix ( su* ,act1 & ?r\gh private 
heal? insurance1 to m9ority populations 
t are disproportionately affect$ by     
kidney disease4  7b7 ,report ,n lat] ?an
 #a ye> aft] ! date ( ! enactm5t ( ?is  

,act1 ! ,secret>y %all submit to        
,congress a report on ! /udy conduct$ "u
 subsection 7a71 toge!r ) su*           
recomm5dations z ! ,secret>y det]m9es to
 be appropriate4  ,,ii ,inc5tiviz+      
kidney c>e innovation  #bja4 ,ref9+ !   
end-/age r5al disease paym5t sy/em to   
improve accuracy 9 paym5t & support     
!rapies  7a7 ,9 g5]al ,section          
#ahha7;b77#ad7 ( ! ,social ,security    
,act 7#db ,u4,s4,c4 #acierr7b77#ad77 is 
am5d$ by add+ at ! end ! foll[+ new     
subp>agraph3  7,j7 ,paym5t = new &      
innovative drugs1 biologicals1 & devices
 t are r5al dialysis s]vices  7i7 ,9    
g5]al ,= any new r5al dialysis drug or  
biological product t is us$ to treat or 
manage a condition = :i* !re is a       
functional category z def9$ 9 section   
#dac4bcd7;a7 ( title #db1 ,code ( ,f$]al
 ,regulations t receiv$ a transitional  
drug add-on adju/m5t 7ref]r$ to 9 ?is   
subp>agraph z ,,tdapa7 "u section       
#dac4bcd7;c77#b7 ( su* title1 & 0       
furni%$ on or aft] ,janu>y #a1 #bjbd1 ! 

,secret>y %all e/abli% a p]man5t add-on 
adju/m5t to ! base rate = claims        
submitt$ on or aft] ,janu>y #a1 #bjbe1 t
 includes ! adm9i/ration ( su* drugs or 
biologicals4  7ii7 ,calculation ( !     
,po/-,,tdapa ,add-on adju/m5t ,9        
calculat+ ! add-on adju/m5t describ$ 9  
clause 7i71 ! ,secret>y %all-- 7,i7 base
 ! calculation on-- 7aa7 except z       
provid$ 9 items 7bb7 & 7cc71 ! mo/ rec5t
 #ab-mon? p]iod ( utilization = ! new   
r5al dialysis drug or biological product
 & ! mo/ rec5t available full cal5d>    
qu>t] ( av]age sales price data = su*   
drug or product2  7bb7 if ! mo/ rec5t   
available full cal5d> qu>t] ( av]age    
sales price data reflects #j or negative
 sales1 #ajj p]c5t ( ! :olesale         
acquisition co/ 7z def9$ 9 section      
#ahdg;,a7c77#f77 ( su* drug or product2 
or  7cc7 if ! :olesale acquisition co/  
is n available1 ! drug manufactur]'s    
invoice2  7,,ii7 calculate ! po/-,,tdapa
 add-on paym5t adju/m5t z ! exp5ditures 
= ! new r5al dialysis drug or biological

 product divid$ by ! total numb] ( r5al 
dialysis s]vices dur+ :i* su* drug or   
biological 0 adm9i/]$ dur+ ! same p]iod2
  7,,iii7 set ! am\nt ( ! add-on        
adju/m5t z an am\nt equal to #fe p]c5t (
 ! am\nt calculat$ "u subclause 7,,ii72 
7,,iv7 update ! add-on adju/m5t annually
 to acc\nt = inflation>y *anges2 &  7,v7
 apply ! add-on adju/m5t am\nt          
imm$iately ^u ! expiration ( ! ,,tdapa  
p]iod & availability ( ! po/-,,tdapa    
add-on adju/m5t4  7iii7 ,implem5tation  
,?is subp>agraph %all n be implem5t$ 9 a
 budget neutral mann] & %all n be adju/$
 by any applicable pati5t-level case-mix
 adju/m5ts describ$ 9 section #dac4bce (
 title #db1 ,code ( ,f$]al ,regulations 
7or any successor regulation74  4  7b7  
,ext5sion ( transitional drug add-,on   
adju/m5t "u ! drug designation policy ,!
 ,secret>y %all pay ! transitional drug 
add-on adju/m5t "u p>agraph 7c7 (       
section #dac4bcd ( title #db1 ,code (   
,f$]al ,regulations 7or a successor     
regulation7 = a total ( #c ye>s = any   

new r5al dialysis drug or biological    
product t-- 7#a7 is us$ to treat or     
manage a condition = :i* !re is a       
functional category z def9$ 9 p>agraph  
7a7 ( su* section2  7#b7 qualifies = su*
 adju/m5t "u p>agraph 7c77#b7 ( su*     
section2 &  7#c7 is furni%$ on or aft]  
,janu>y #a1 #bjbd4  7c7 ,new devices &  
o!r te*nologies  7#a7 ,9 g5]al ,z "p ( !
 promulgation ( ! annual rule = !       
,m$ic>e end-/age r5al disease           
prospective paym5t sy/em "u section     
#ahha7;b77#ad7 ( ! ,social ,security    
,act 7#db ,u4,s4,c4 #acierr7b77#ad77 =  
cal5d> ye> #bjbf1 & 9 consultation )    
/akehold]s1 ! ,secret>y ( ,heal? &      
,human ,s]vices 7ref]r$ to 9 ?is        
subsection z ! ,secret>y7 %all-- 7,a7   
ensure t ! s+le paym5t am\nt is adequate
 to cov] ! co/ ( any new innovative     
device or o!r te*nology ) sub/antial    
cl9ical improvem5t2 &  7,b7 increase !  
s+le paym5t am\nt if ! ,secret>y        
det]m9es su* paym5t am\nt is n adequate 
to cov] su* co/4  7#b7 ,co/ &           

utilization data ,9 c>ry+ out p>agraph  
7#a71 ! ,secret>y %all use ! co/ &      
utilization data collect$ dur+ a #c-ye> 
transitional paym5t p]iod1 z describ$ 9 
! f9al regulation publi%$ on ,novemb]   
#i1 #bjbj 7#he ,f$4 ,reg4 #gacih74      
#bjb4 ,ensur+ ,m$ic>e ,advantage        
supports kidney c>e innovative !rapies  
,section #ahec7;c7 ( ! ,social ,security
 ,act 7#db ,u4,s4,c4 #aciew-#bc7;c77 is 
am5d$ by add+ at ! end ! foll[+ new     
p>agraph3  7#h7 ,treatm5t ( innovative  
products = enrollees ) end /age r5al    
disease  7,a7 ,9 g5]al ,! ,secret>y %all
 make direct paym5t adju/m5ts to        
provid]s ( s]vices or r5al dialysis     
facilities =-- 7i7 any new r5al dialysis
 drug or biological product t receives a
 transitional drug add-on adju/m5t "u   
section #dac4bcd7;c7 ( title #db1 ,code 
( ,f$]al ,regulations2 or  7ii7 an item 
or s]vice t receives a transitional     
add-on paym5t adju/m5t = new &          
innovative equipm5t & supplies "u       
section #dac4bcf ( su* title4  7,b7     

,am\nt ( direct paym5t ,! am\nt ( !     
adju/m5t %all equal ! am\nt det]m9$ "u !
 end /age r5al disease prospective      
paym5t sy/em describ$ 9 section         
#ahha7;b77#ad74  7,c7 ,duration ( direct
 paym5t ,! ,secret>y %all make paym5ts  
"u subp>agraph 7,a7 = ! duration ( !    
transitional paym5t "u ! end /age r5al  
disease prospective paym5t sy/em        
describ$ 9 su* section4  4  #bjc4       
,improv+ pati5t lives & quality ( c>e   
?r\gh rese>* & innovation  7a7 ,/udy ,! 
,secret>y ( ,heal? & ,human ,s]vices    
7ref]r$ to 9 ?is section z ! ,secret>y7 
%all conduct a /udy on increas+ kidney  
transplantation rates4 ,su* /udy %all   
include an analysis ( ea* ( ! foll[+3   
7#a7 ,any dis9c5tives 9 ! paym5t sy/ems 
"u ! ,m$ic>e program "u title ,,xviii ( 
! ,social ,security ,act 7#db ,u4,s4,c4 
#acie et seq47 t create b>ri]s to kidney
 transplants & po/-transplant c>e =     
b5efici>ies ) end-/age r5al disease4    
7#b7 ,! practices us$ by donation s]vice
 areas ) high] ?an av]age donation rates

 & :e!r ^? practices & policies c\ld be 
successfully utiliz$ 9 o!r donation     
s]vice areas4  7#c7 ,practices &        
policies t c\ld increase donation rates 
among m9ority populations4  7#d7 ,:e!r  
cultural & policy b>ri]s exi/ to        
increas+ liv+ donation rates1 includ+ an
 exam9ation ( h[ to bett] facilitate    
kidney pair$ donations4  7#e7 ,crit]ia =
 transplant recipi5ts = ref]ral & =     
gett+ on ! waitli/ to receive a kidney4 
7#f7 ,o!r areas det]m9$ appropriate by !
 ,secret>y4  7b7 ,report ,n lat] ?an #ah
 mon?s aft] ! date ( enactm5t ( ?is     
,act1 ! ,secret>y %all submit to        
,congress a report on ! /udy conduct$   
pursuant to subsection 7a71 toge!r ) su*
 recomm5dations z ! ,secret>y det]m9es  
to be appropriate4  ,,iii ,increas+     
pati5t access to quality p]=mance by    
improv+ ! accuracy & transp>5cy (       
end-/age r5al disease quality programs  
#cja4 ,improv+ pati5t decision mak+ &   
transp>5cy by consolidat+ & mod]niz+    
quality programs  7a7 ,measures ,section

 #ahha7;h77#b7 ( ! ,social ,security    
,act 7#db ,u4,s4,c4 #acierr7h77#b77 is  
am5d$-- 7#a7 by /rik+ subp>agraph 7,a7 &
 ins]t+ ! foll[+3  7,a7 ,! measures     
specifi$ "u ?is p>agraph ) respect to ! 
ye> involv$ %all be select$ by !        
,secret>y 9 consultation ) /akehold]s to
 promote improvem5t 9 b5efici>y outcomes
 & %>$ decision-mak+ ) b5efici>ies & _! 
c>egiv]s4 ,:5 select+ measures specifi$ 
"u ?is p>agraph1 ! ,secret>y %all take  
into acc\nt cl9ical gaps 9 c>e1         
und]utilization t may lead to b5efici>y 
h>m1 pati5t safety1 & outcomes4  2  7#b7
 9 subp>agraph 7,b77i71 by /rik+        
subp>agraph 7,a77iv7 & ins]t+           
subp>agraph 7,a72  7#c7 by /rik+        
subp>agraph 7,e72 &  7#d7 by add+ at !  
end ! foll[+ new subp>agraphs3  7,e7    
,weight+ limitation ,no s+le measure    
specifi$ by ! ,secret>y or individual   
measure )9 a composite measure s        
specifi$ may be weight$ less ?an #aj    
p]c5t ( ! total p]=mance score4  7,f7   
,/ati/ically valid & reliable ,9        

specify+ measures "u subp>agraph 7,a71 !
 ,secret>y %all only specify measures t 
h be5 %[n to be /ati/ically valid &     
reliable ?r\gh te/+4  4  7b7 ,endorsem5t
 ,section #ahha7;h77#b77;,b77ii7 ( !    
,social ,security ,act 7#db ,u4,s4,c4   
#acierr7h77#b77;,b77ii77 is am5d$ by    
add+ at ! end ! foll[+ new s5t5ce3 ,!   
exception "u ! prec$+ s5t5ce %all n     
apply to a measure t ! entity ) a       
contract "u section #ahij7;a7 7or a     
simil> entity7 consid]$ b fail$ to      
endorse44  7e7 ,effective date ,!       
am5dm5ts made by ?is section %all apply 
to items & s]vices furni%$ on or aft]   
,janu>y #a1 #bjbe4  ,,iv ,emp[]+ pati5ts
  #dja4 ,m$igap cov]age = b5efici>ies ) 
end-/age r5al disease  7a7 ,gu>ante$    
availability ( ,m$igap policies to all  
,,esrd ,m$ic>e b5efici>ies  7#a7 ,9     
g5]al ,section #ahhb7s7 ( ! ,social     
,security ,act 7#db ,u4,s4,c4           
#aciess7s77 is am5d$-- 7,a7 9 p>agraph  
7#b7-- 7i7 9 subp>agraph 7,a71 by /rik+ 
is #fe & all t foll[s ?r\gh ! p]iod &   

ins]t+ ! foll[+3 8is--  7i7 #fe ye>s (  
age or old] & is enroll$ = b5efits "u "p
 ,b2 or  7ii7 entitl$ to b5efits "u     
#bbf;,a7b7 & is enroll$ = b5efits "u "p 
,b4  2 &  7ii7 9 subp>agraph 7,d71 9 !  
matt] prec$+ clause 7i71 by ins]t+ 7or  
is entitl$ to b5efits "u #bbf;,a7b77    
aft] is #fe ye>s ( age or old]2 &  7,b7 
9 p>agraph 7#c77;,b7-- 7i7 9 clause     
7ii71 by ins]t+ 7or is entitl$ to       
b5efits "u #bbf;,a7b77 aft] is #fe ye>s 
( age or old]2 &  7ii7 9 clause 7vi71 by
 ins]t+ 7or "u #bbf;,a7b77 aft] at age  
#fe4  7#b7 ,effective date ,! am5dm5ts  
made by p>agraph 7#a7 %all apply to     
,m$ic>e supplem5tal policies effective  
on or aft] ,janu>y #a1 #bjbf4  7b7      
,additional enrollm5t p]iod = c]ta9     
individuals  7#a7 ,"o-"t enrollm5t p]iod
  7,a7 ,9 g5]al ,9 ! case ( an          
individual describ$ 9 subp>agraph 7,b71 
! ,secret>y ( ,heal? & ,human ,s]vices  
%all e/abli% a "o-"t enrollm5t p]iod    
dur+ :i* su* an individual may enroll 9 
any ,m$ic>e supplem5tal policy "u       

section #ahhb ( ! ,social ,security ,act
 7#db ,u4,s4,c4 #aciess7 ( !            
individual's *oos+4  7,b7 ,enrollm5t    
p]iod ,! enrollm5t p]iod e/abli%$ "u    
subp>agraph 7,a7 %all beg9 on ,janu>y   
#a1 #bjbf1 & %all end ,june #cj1 #bjbf4 
7#b7 ,individual describ$ ,an individual
 describ$ 9 ?is p>agraph is an          
individual :o-- 7,a7 is entitl$ to      
hospital insurance b5efits "u "p ,a (   
title ,,xviii ( ! ,social ,security ,act
 "u section #bbf;,a7b7 ( su* ,act 7#db  
,u4,s4,c4 #dbf-a72  7,b7 is enroll$ =   
b5efits "u "p ,b ( su* title ,,xviii2 & 
7,c7 w\ld n1 b = ! provisions (1 &      
am5dm5ts made by1 subsection 7a7 be     
eligible = ! gu>ante$ issue ( a ,m$ic>e 
supplem5tal policy "u p>agraph 7#b7 or  
7#c7 ( section #ahhb7s7 ( su* ,act 7#db 
,u4,s4,c4 #aciess7s774